For the first time since being granted regulatory authority over tobacco, the FDA has given the green light to two new cigarette brands.
Using oversight powers awarded four years ago through passage of the Family Smoking Prevention and Tobacco Control Act, the agency also rejected four other brands.
The new Newport non-menthol cigarettes receiving the go-ahead got it not for being less harmful than cigarettes already on the market, but because the manufacturer showed that they would not be more harmful, said Mitchell Zeller, director of the FDA’s Center for Tobacco Products.
“Substantial equivalence (SE) is one pathway manufacturers can use to market new tobacco products…. [It] does not mean that the agency considers a product to be safe, nor is it FDA-approved,” explained Zeller on the agency blog, FDA Voice. “The SE decision only means that a new product does not raise different questions of public health as compared to the predicate [established] product.”
Zeller said the four brands that did not pass FDA muster were rejected due to insufficient information from the manufacturers about ingredients, thus raising concerns about potential new health risks.
An estimated 4000 applications for tobacco products are under review by the FDA. Most of these submissions concern products that are already on the market and, in many cases, have been on the market for years. However, in accordance with the law, until their reviews are completed and dictate otherwise, tobacco products that were on the market as of February 2007 and which had applications submitted by the FDA’s March 2011 deadline can continue to be sold.
Zeller said the FDA is working to clear the backlog and expects the reviews will become less time consuming as those involved in the process gain experience.
[Janet Lubman Rathner]